USA Today Expose Antipsychotics Killed at least 45 Children_FDA Not Concerned

May 4, 2006

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Promoting Openness, Full Disclosure, and Accountability

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" I trusted the doctors, I trusted the FDA ... and I feel betrayed by

both, "

says , the mother of Rex who was prescribed the 'atypical'

antipsychotic, Risperdal (risperidone) at age 8. The drug damaged his

brain--he now has to live with tardive dyskinesia (TD), an irreversible,

severely disfiguring, neurological condition which is a risk linked to ALL

antipsychotics. The manufacturer, Janssen, says, " Nobody knows how many

children on atypicals get TD, but it's rare in adults. "

An investigative report in USA Today (below) documents the awful truth about

antipsychotic drug-induced harm being perpetrated on America's

children--while FDA officials pretend nothing out of the ordinary is

happening.

Marilyn Elis of USA TODAY reviewed FDA's Medwatch adverse event report

database (from 2000 to 2004) and found " at least 45 deaths of children in

which an atypical anti-psychotic was listed as the " primary suspect. "

One-fourth of the cases in the database did not list the patient's age. In

addition, there were 1,328 reports of bad side effects, some of them

life-threatening.

The Medwatch database represents only 1% to 10% of drug-induced side effects

and deaths. Expert clinical pharmacologist Alastair J.J. Wood (Vandebilt

University) suggests it represents, " maybe even less than 1%. "

When confronted with children's death toll, Laughren, director of

FDA's division of psychiatry products, is quoted stating: " we haven't been

alerted to any particular or unusual concern. The effects (in kids) are

similar to what we're seeing in adults. We have not systematically looked at

the data for children " because the drugs aren't approved for them. "

Among the life-threatening adverse events reported to Medwatch: 41 children

nearly died of a drug-induced toxic reaction--neuroleptic malignant syndrome

NMS). Child psychiatrist ph Penn of Bradley Hospital and Brown

University School of Medicine, said NMS was the most troubling effect

listed. " It is life-threatening and can kill within 24 hours of diagnosis.

It's been linked to drugs that act on the brain's dopamine receptors, which

would include the atypicals. "

Antipsychotic drugs are the most toxic of all psychotropic drugs--they are

approved for adults disabled by schizophrenia and for short-term use in

patients with manic-depression (bipolar). Yet, a Vanderbilt study found that

more than 2.5 million children--some as young as 18 months--are being

prescribed these toxic drugs without parents ever being told about the harm

these drugs might cause--

Dr. Findling, a child psychiatrist at University Hospitals of

Cleveland, states: " These anti-psychotics are the most widely used class of

drugs to treat disruptive kids who attack others and defy adults. Again,

there's a paucity of proof that the drugs help. "

Whereas other studies of psychotropic drug prescribing for children reviewed

Medicaid records, USA TODAY contracted Medco to do an analysis of outpatient

prescriptions for children who are privately insured. In a sampling of

about 2.5 million of Medco's 55 million members, they found the rate of

children 19 and under with at least one atypical prescription jumped 80%

from 2001 to 2005 - from 3.6 per 1,000 to 6.5 per 1,000.

USA Today investigated the dark side of current practice by mental health

professionals--some call it criminal malpractice and child abuse. They bring

to public attention how children are being victimized by irresponsible

doctors whose aggressive prescribing of antipsychotic drugs for children has

run amok-the consequences are borne by children, some of who are brain

damaged, disabled, or dead. This is the story The New York Times wouldn't

touch!

More than half of the kids who died were on at least one other psychiatric

drug besides the atypical anti-psychotic, and many were taking drugs for

other ailments. The youngest, a 4-year-old boy whose symptoms suggested

diabetes complications, was taking 10 other drugs. "

" Some parents tell stories of serious effects that linger long after their

kids stop taking the drugs. Rex ' parents are bitter about what

happened to their son. They believe the 13-year-old Colorado Springs boy was

harmed permanently by an atypical anti-psychotic he took several years ago.

Rex now has a serious case of tardive dyskinesia (TD), suffering daily

episodes of involuntary jerking movements and facial grimacing, says

, his mother. " " An 8-year-old boy had cardiac arrest. A 15-year-old boy

died of an overdose. A 13-year-old girl experienced diabetic ketoacidosis, a

deficiency of insulin.

The story of Evan Kitchens who had problems from birth, having suffered from

lack of oxygen during a difficult delivery, is an indictment of psychiatry

and its obsession with drugs. Beginning at 18 months, Evan was prescribed

one after another psychotropic drug which exacerbated whatever troubling

behavior he exhibited--his " diagnoses " shifting with the drugs and drug

cocktails. The child was prescribed his first of several antipsychotic drugs

at age 3 1/2. Until he was finally taken off drugs he says he was in a fog.

His mother wishes she had gone the non-drug route earlier. " I didn't even

know what was available ... I totally relied on the doctors. "

is one parent who wishes she had never heard of anti-psychotics.

Her son, Rex, was prescribed Risperdal at age 8: " After one month on

Risperdal, Rex started having tremors; within a few months, his hands shook

so severely that he could barely write at school, " and I'd have to guide the

cup of milk to his mouth in the morning, " says. But the psychiatrist

said the tremors weren't so bad, says, and urged the family to

continue the drug. The psychiatrist didn't pressure them, she says, " but

I'm from the generation where, when a doctor says something, you believe

it. "

" The parents started to learn more about Risperdal and, for the first time,

they realized that Rex's symptoms could be side effects, so they started to

wean him off the drug. In a few weeks they noticed his jaw was scrunching up

and his facial expressions were becoming distorted. By then, says, she

had read up on tardive dyskinesia (TD), a neurological disorder that can be

caused by anti-psychotics. Rex became less anxious, but the TD worsened. " He

had a horrible, ugly look on his face all the time, " says. Friends no

longer came to play. Rex went from winning an award for best reader in the

third grade to claiming he couldn't remember how to spell his own name in

fourth grade. "

When confronted with the evidence, some of psychiatry's leading child

psychiatrists, for the first time, disavowed current prescribing practices,

including the loose labeling of children as " bipolar: "

Dr. March (Duke University) acknowledges, " We have no evidence about

the safety of these agents or their effectiveness in controlling

aggression, " he says. " Why are we doing this? "

Kuhn, a Duke University pharmacologist is aghast as well: " The brain

system that the drugs work on develops through childhood and adolescence.

We really don't know the impact of chronically perturbing that system in

childhood. "

Dr. Jensen, head of Columbia University's center for advancing

childrent's mental health, expressed concern about over-diagnosis and

" jumping to this (bipolar) label too quickly. "

Dr. Barbara Geller, one of the major proponents of diagnosing children as

bipolar, who served on the influential psychotropic drug prescribing

guideline pane that helped encourage the prescribing of antipsychotics for

children (TMAP), made an astounding statement, acknowledging the absence of

science in psychiatry: " The science is nowhere near where it is in other

branches of medicine. "

Yet, (as is documented in today's companion Infomail) academic psychiatrists

whose financial ties to drug manufacturers has been the subject of criticism

on both sides of the Atlantic, are conducting experiments whose risk/

benefit ratio for the child subjects is disadvantageous. The only plausible

purpose for conducting such experiments is commercial: to legitimize

illegitimate, off-label prescribing of toxic drugs for children-as described

in the USA Today report. These commercially driven experiments are designed

to demonstrate short-term efficacy which would justify wide prescribing.

The evidence presented in this series is an indictment of current

prescribing practice which is rooted in: the absence of science, the absence

of reliable diagnostic tools, often resulting in misdiagnosis, parents'

ignorance and doctors denial / concealment of these drugs' harmful

effects-both short-term and irreversible. Finally, the unprecedented

prescribing of such toxic drugs mostly to control behavior, not illness.

However, USA Today's choice of organizations to which families seeking

information are sent, undermines the message. Readers are referred to

websites of organizations that are the very promoters of psychotropic drug

treatment and the pathologizing of children. They promoted psychotropic

drugs claiming they were " safe and effective " -even as black box warnings

were added to the labels. These organizations have financial a stake in the

psychotropic drug industry which supports them. Either the editor didn't

understand the reason children are suffering and dying from drugs they

should not be exposed to, or he is sabotaging this powerful investigative

news report.

These are the very groups that have contributed to the problems described in

the series.

The Academy of Child and Adolescent Psychiatry, Child & Adolescent Bipolar

Foundation (bpkids), the NIMH, First Signs.

See list of Pharma supporters:

http://www.bpkids.org/site/PageServer?pagename=ppl_organizational_donors

For credible information about the drugs, the science, the profitability of

these drugs-and for other credible sources of information, visit the AHRP

website.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

http://www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm

USA TODAY: New anti-psychotic drugs carry risks for children By Marilyn

Elias,

5/2/2006 1:20 AM ET

remembers the bad old days when she had to wear long-sleeve

clothes to church to cover bite marks all over her arms from her daughter

a's rages.

At age 8, a was diagnosed with bipolar disorder. She was a violent child

with sharp mood swings and meltdowns that drove her to tear up the house.

Antidepressants and drugs for attention-deficit disorder had only made a

more aggressive, says.

A mix of medicines including so-called atypical anti-psychotics - drugs

approved only for adults - finally stabilized a's moods. Now at 15, she

is able to live a more normal life - as long as she takes the medication.

Even so, the ville, Mo., teen is paying a price: On one of the

atypical anti-psychotics, a gained about 100 pounds in a year, putting

her at risk for a host of health problems, including diabetes. It has taken

her three years to lose a third of that extra weight; she is still

struggling with the rest.

Atypicals are a new generation of anti-psychotic drugs approved by the Food

and Drug Administration for adult schizophrenia and bipolar disorder (manic

depression). None of the six drugs - Clozaril, Risperdal, Zyprexa, Seroquel,

Abilify and Geodon - is approved for kids, but doctors can prescribe them as

" off-label " medications.

Psychiatrists say the drugs can be helpful for children with serious mental

illnesses and have been known to save young lives. But diagnosis often is

difficult, making appropriate prescribing tricky. And many experts,

including behavioral pediatrician Lawrence Diller, author of Should I

Medicate My Child?, say there is growing overuse of these powerful

anti-psychotics.

Schizophrenia is rare in children under 18: It strikes about 1 in 40,000, as

opposed to 1 in 100 adults, according to the National Institute of Mental

Health. Nobody knows exactly how many kids have bipolar disorder;

psychiatrists don't even agree on criteria to diagnose the disease in

childhood.

Research on how the drugs affect children is sparse, and experts

increasingly are concerned that the drugs are being prescribed too often for

children with behavior problems, such as attention-deficit disorder and

aggression.

March, chief of child and adolescent psychiatry at Duke University

School of Medicine, prescribes the drugs to kids in some cases of serious

illness when he thinks the benefits outweigh the risks. But he says

prescribing them for behavior problems alone may be a mistake. " We have no

evidence about the safety of these agents or their effectiveness in

controlling aggression, " he says. " Why are we doing this? "

At the same time, reports of deaths and dangerous side effects linked to the

drugs are mounting. A USA TODAY study of FDA data collected from 2000 to

2004 shows at least 45 deaths of children in which an atypical

anti-psychotic was listed in the FDA database as the " primary suspect. "

There also were 1,328 reports of bad side effects, some of them

life-threatening.

Drug companies are required to file any reports they have to the FDA, but

consumers and doctors report such events on a voluntary basis. Studies

suggest the FDA's Adverse Events Reporting System database captures only 1%

to 10% of drug-induced side effects and deaths, " maybe even less than 1%, "

says clinical pharmacologist Alastair J.J. Wood, an associate dean at

Vanderbilt Medical School in Nashville. So the real number of cases is

almost certainly much higher.

" We're conducting a very large experiment on our children, " March says.

Side effects that linger

Some parents tell stories of serious effects that linger long after their

kids stop taking the drugs. Rex ' parents are bitter about what

happened to their son. They believe the 13-year-old Colorado Springs boy was

harmed permanently by an atypical anti-psychotic he took several years ago.

Rex now has a serious case of tardive dyskinesia (TD), suffering daily

episodes of involuntary jerking movements and facial grimacing, says

, his mother.

Anti-psychotics are known to cause TD, but it's thought to be a rare effect

for the newer atypicals. Despite such reports, outpatient prescriptions for

kids ages 2 to 18 leaped fivefold - from just under half a million to about

2.5 million - from 1995 to 2002, according to a new analysis of a federal

survey by Vanderbilt Medical School researchers. This doesn't include

prescriptions at psychiatric hospitals or residential treatment centers.

And even though the drugs are approved only for adults, the rate of children

treated with atypicals " is growing dramatically faster than the rate for

adults, " says Epstein, chief medical officer for Medco Health

Solutions, pharmacy benefit managers.

Medco did an analysis of outpatient prescriptions for USA TODAY and found

that, in a sampling of about 2.5 million of Medco's 55 million members, the

rate of children 19 and under with at least one atypical prescription jumped

80% from 2001 to 2005 - from 3.6 per 1,000 to 6.5 per 1,000. And that only

represents kids who are privately insured, not those in foster care or

others on Medicaid.

" We know these are very strong medicines, " Epstein says. " You'd want to be

absolutely sure the child needs it. "

The more serious risks

Because of the nature of the FDA data, they don't prove that these drugs

caused the deaths or the side effects. Many side effects for which an

atypical is listed as the " primary suspect " occurred in the normal course of

using the drug, but the database also includes cases involving drug abuse,

overdoses, suicides and homicides. Entries are sometimes cryptic, and the

FDA enters verbatim - misspellings and all - what's reported on the form.

Still, the data " can be a useful signaling device " suggesting problems with

a drug that warrant conclusive studies, says Jerome Avorn, a pharmacology

specialist at Harvard Medical School and author of the book Powerful

Medicines.

One-fourth of the cases in the database studied by USA TODAY did not list

the patient's age. But in cases that listed an age under 18:

..A condition called dystonia was most often cited as an " adverse event "

suffered by someone taking one of the drugs, with 103 reports. Dystonia

produces involuntary, often painful muscle contractions.

..Tremors, weight gain and sedation often were cited, along with neurological

effects such as TD. Symptoms of TD can vary from slight twitching to

full-blown jerking of the body.

..A condition called neuroleptic malignant syndrome, with 41 pediatric cases

over the five years, was the most troubling effect listed, says child

psychiatrist ph Penn of Bradley Hospital and Brown University School of

Medicine. It is life-threatening and can kill within 24 hours of diagnosis.

It's been linked to drugs that act on the brain's dopamine receptors, which

would include the atypicals, Penn says.

The FDA office of drug safety checks the database, " and we haven't been

alerted to any particular or unusual concern, " says Laughren,

director of the agency's division of psychiatry products. " The effects (in

kids) are similar to what we're seeing in adults. We have not systematically

looked at the data for children " because the drugs aren't approved for them,

he says.

The 45 deaths

Among the 45 pediatric deaths in which atypicals were the primary suspect,

at least six were related to diabetes - atypicals carry warnings that the

drugs may increase the risk of high blood sugar and diabetes. Other causes

of death ranged from heart and pulmonary problems to suicide, choking and

liver failure.

An 8-year-old boy had cardiac arrest. A 15-year-old boy died of an overdose.

A 13-year-old girl experienced diabetic ketoacidosis, a deficiency of

insulin.

More than half of the kids who died were on at least one other psychiatric

drug besides the atypical anti-psychotic, and many were taking drugs for

other ailments.

The youngest, a 4-year-old boy whose symptoms suggested diabetes

complications, was taking 10 other drugs. The reports don't tell the child's

general state of health or other factors that could predispose him to

trouble. Also, neither Clozaril, which is rarely used, nor Abilify, the

newest atypical, was listed as a primary suspect in any deaths.

All the drugmakers emphasize that their products are not approved for

children, and they say the drugs are safe and effective for adults with

schizophrenia or bipolar disorder who are monitored for side effects. Still,

" there are worrisome questions here, " says Avorn. Large, longer-term

database studies could provide answers, he says.

There's some evidence that the drugs can help young schizophrenics and may

be helpful in treating bipolar disorder in children, says Findling, a

child psychiatrist at University Hospitals of Cleveland. But the data from

controlled studies " are too few to guide treatment decisions " on bipolar

disorder, concluded Findling's research team in a summary of pediatric

studies published in the Journal of Clinical Psychiatry.

These anti-psychotics are the most widely used class of drugs to treat

disruptive kids who attack others and defy adults, Findling says. Again,

there's a paucity of proof that the drugs help. There are only a handful of

carefully controlled, sizable studies testing the drugs for any pediatric

disorder, and they're mostly short-term, says Benedetto Vitiello, chief of

child and adolescent psychiatry at the national mental health institute. The

most serious, widespread problem found to be caused by the medicines is

weight gain, he says. The effect varies by drug, but kids typically put on

twice the pounds they should in their first six months on atypicals.

In the first three months on the drugs, children add about 2 to 3 inches to

their waistlines, says research psychiatrist Christoph Correll of Zucker

Hillside Hospital in Glen Oaks, N.Y. A lot of this is abdominal fat, which

increases the risk of diabetes and heart disease. Obese children are twice

as likely as normal-weight children to have diabetes, according to a new

University of Michigan study.

" Some patients gain weight on Zyprexa and others do not, " says Calvin

Sumner, a medical adviser to Eli Lilly Research Laboratories. Lilly makes

the drug, which has been associated with weight gains in adult studies.

Sumner stresses that Zyprexa isn't approved for kids.

There's no proof atypicals cause diabetes, says Ramy Mahmoud of Janssen LP,

maker of Risperdal. He says the FDA added a label warning of increased

diabetes risk " to make people aware of the possibility. "

One key question about atypicals is whether they will have long-term,

unknown effects on the brains of children. The brain system that the drugs

work on develops through childhood and adolescence, says Kuhn, a

Duke University pharmacologist. " We really don't know the impact of

chronically perturbing that system in childhood. "

Why atypicals get prescribed

Given all the potential problems, why would doctors prescribe these drugs to

children to begin with? Nobody disputes that the lives of schizophrenic or

severely manic children may be saved by anti-psychotics. " I use them myself

for patients, " says March, the Duke psychiatrist. " I have a 9-year-old who

threatened to jump out of a second-story window if her mom didn't give her

the car keys to drive down to the 7-Eleven to get a Coke. If I took her off

anti-psychotics, she'd disintegrate. "

But several factors can lead to misprescribing of anti-psychotics.

It can be difficult to tell one behavioral disorder or illness from another

in kids. For example, the aggression and irritability of bipolar disorder

can mimic attention-deficit hyperactivity disorder or depression, the mental

health institute says. Also, the environment can be a key cause of symptoms

that may be mistakenly diagnosed as mental disorders, says Diller, the

behavioral pediatrician.

Some events in a child's life can trigger acting-out or other symptoms.

Adults can explain what happened to them; children, especially the youngest,

may be more reticent.

Doctors often face time pressures that prevent them from finding out what's

going on in kids' lives, knowledge that might suggest alternative

treatments, Penn says. For example, abuse of drugs such as methamphetamine,

OxyContin and cocaine is fairly common among teens, he says. Kids begin

acting strangely, hearing voices, becoming paranoid. The symptoms can mimic

psychosis or behavioral disorders, and doctors can end up giving these

children unneeded anti-psychotic drugs, he says.

Insurance coverage rules may encourage the soaring use of anti-psychotics

for children, as well. " With some companies, the only thing they reimburse

for is prescribing. There's little or no therapy, " says Brown, editor

of the Journal of Pediatric Psychology and a dean at Temple University.

Also, kids with serious mental health problems often have at least one

hospitalization, but policies cover only a week or two. It can take a couple

of weeks just to get medical records and family histories, Penn says, but

insurers often extend time if there's a new medicine started, which

encourages drug dabbling for children who are not ready to go home. In the

end, some parents say their children have such severe behavior disorders or

mental illness that the benefits outweigh risks.

Parents of children such as a , who have bipolar disorder, say the

atypicals often help. " We were very fortunate, " says a's mother,

special-education director for the ville, Mo., school district. " The

medication worked for my daughter. It doesn't work for everybody. "

Misdiagnosis common

The Vanderbilt study of anti-psychotic prescribing finds at least 13% of

pediatric prescriptions are for bipolar disorder. But there is some concern

about over-diagnosis and " jumping to this (bipolar) label too quickly, " says

psychiatrist Jensen, head of the Center for the Advancement of

Children's Mental Health at Columbia University.

Spencer's son, , was diagnosed as bipolar at age 6 and put on

atypicals. He developed liver abnormalities and obesity, his mother says.

" He's been on a smorgasbord of meds, " she says. None worked well for very

long. By the time he was in sixth grade, doctors said they weren't sure

was bipolar after all. Now 15, he is on low doses of an

antidepressant and mood stabilizer. He's being weaned off both, says

Spencer, executive director of the Federation of Families for Children's

Mental Health, a support group.

She worries about how the drugs have affected , who is black: As

little psychiatric drug research as there is on children, there's least of

all on minority kids. Some drugs are known to affect black adults

differently from whites. " He probably had ADHD all along, " Spencer says.

" Psychiatry is so not an exact science. "

Child psychiatrist Barbara Geller, a bipolar expert at Washington University

in St. Louis, agrees: " The science is nowhere near where it is in other

branches of medicine. "

So parents struggle to make the right decisions for very troubled kids.

" There's a lot of fear among parents, " Spencer says. " You don't know what

the effects of these drugs are going to be. You're at the mercy of your

doctor. " I have had to make a lot of decisions, and they were fear-driven.

You don't have enough information to make an intelligent decision. "

Contributing: O' Copyright C 2006 USA TODAY

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May 4, 2006